BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X360MM X 125°

    MDR report key: 3132158 · Received May 29, 2013

    Report

    Report Number
    0009610622-2013-00285
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED. THE LONG NAIL KIT WAS CLASSIFIED AS PRIMARY PRODUCT DURING INVESTIGATION. NO DEVIATIONS WERE FOUND DURING REVIEW OF THE MANUFACTURING AND INSPECTION DOCUMENTS (DHR). ALTHOUGH THE DEVICE WAS NOT AVAILABLE INVESTIGATION REVEALED THAT THERE IS A HIGH POTENTIAL THAT THE LASER MARKING ON THE NAIL IS INCORRECT. NO DISCREPANCIES WERE DETECTED DURING RISK ANALYSIS REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OBSERVED THAT THE GAMMA NAIL WAS LABELED AS A RIGHT ONE, BUT IT WAS A LEFT ONE. ALL OTHER INDICATIONS SHOW THAT THIS IS A LEFT NAIL. THE NAIL HAS BEEN IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON OBSERVED THAT THE GAMMA NAIL WAS LABELED AS A RIGHT ONE, BUT IT WAS A LEFT ONE. ALL OTHER INDICATIONS SHOW THAT THIS IS A LEFT NAIL. THE NAIL HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236851 LONG NAIL KIT R2.0, TI, LEFT GAMMA3 Ø11X360MM X 125° IMPLANT HSB STRYKER OSTEOSYNTHESIS-KIEL K245253

    Patients

    Seq Age Sex Outcome Treatment
    1 Other